FDA Grants First Traditional Clearance for COVID-19 Test

The FDA has given its first traditional regulatory clearance to a COVID-19 test, granting De Novo clearance for BioFire Diagnostics’ BioFire Respiratory Panel 2.1.

The diagnostic, which uses nasopharyngeal swabs to detect and differentiate between SARS-CoV-2 and other respiratory viruses, previously received Emergency Use Authorization from the FDA but has now received De Novo clearance after additional data were evaluated. The agency said it reviewed data from a clinical study comprising more than 500 test samples and a number of analytical studies that gave reasonable assurance the test was safe and effective.

The test is cleared for use only in patients suspected of respiratory tract infections, including COVID-19. With the agency’s first full approval for a COVID-19 diagnostic, tests of the same type may now go through its 510(k) pathway for potential clearance.